Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

Dietary Supplementation of Lactogyn in Women With Bacterial Vaginosis: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601429
• Other study ID #: BV-SVG-A001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: April 2019
• Source: Vesale Pharmaceutica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to determine clinical efficacy of Lactogyn (Lactobacillus Crispatus, L. brevis, L.acidophilus) in prevention of recurrent BV

Description:

According to classification, this is a phase 2 randomized parallel group prospective controlled dietary study to evaluate efficacy of a dietary supplement, a combination of L. crispatus LMG S-29995, L. brevis, and L. acidophilus in women aged from 18 through 45 years suffering from rBV. The 2 phase of the study has been ascribed as there is no evidence that oral capsules with L. crispatus LMG S-29995, L. brevis, and L. acidophilus have a potential efficacy in rBV.

Qualifying women received a combination of the three probiotic strains with a half daily recommended dose of vitamin C or just vitamin C without probiotics, a control supplementation, via oral route of administration for up to 120 days. During the intake of active or control formulations, participants kept a structured 120-DSD, where they recorded test capsules intake, screen for symptoms of bacterial vaginosis, and food intolerance events.

Based on repeat physical examination with application of Amsel and Nugent criteria the main conclusions over the efficacy of probiotic strains were made.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria

1. Informed consent form signed;

2. Age: 18-45 years;

3. Able to swallow capsules;

4. Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days;

5. Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria;

6. Willing to communicate intimate history for the study purposes;

7. Consent not to use spermicides for 4 months after starting TDC;

8. Stated availability throughout the study period and a mobile phone.

Exclusion criteria

1. Post-menopausal;

2. Pregnancy or high risk of;

3. Breast feeding;

4. Currently active STD as determined by history, physical examination, and laboratory tests;

5. Diabetes mellitus;

6. Inflammatory bowel disease;

7. Alcohol or drug addiction as guessed by investigator;

8. Absence of refrigerator;

9. Known moderate to severe disease of any systems;

10. Difficulty to comprehend study requirements as judged by physician;

11. Any erosions, herpes like lesions, cervicitis during vaginal examination;

12. Treatment of BV with other than metronidazole antibiotic;

13. Use of any investigational drug within the previous 30 days;

14. Use of drugs that suppress the immune system.

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Dietary Supplement:
• Lactogyn
capsules
• Placebo
capsules

Locations

Country	Name	City	State
Ukraine	Sergiy V. Gerasymov, MD, PhD	Lviv

Sponsors (1)

Lead Sponsor	Collaborator
Vesale Pharmaceutica

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in recurrence of BV during Lactogyn supplementation	Percent change in recurrence of BV during the 4 months of dietary supplementation	4 months